Fibroblast Growth Factor-1 (FGF-1) for the Treatment of Coronary Heart Disease

Exclusion Criteria

• •1. History of undergoing a CABG, PTCA or TMR or evidence of an acute MI in the last 3 months.
• •2. Subjects with malignancies or a history of malignancies (with the exception of basal cell carcinoma \[BCC\] of the skin) will be excluded from the study. Those subjects with a history of BCC are eligible for enrollment, and will be monitored by a qualified dermatologist every 8 weeks for a period of 6 months for evaluation of their skin condition. Subjects with existing BCC will be excluded from the study.
• •3. Evidence of concurrent clinically significant infection (e.g. elevated white blood cell \[WBC\] count \>13,000 x 109/L, temperature \>38.5°C), evidence of "common cold" or "flu."
• •4. Concomitant other structural heart disease, such as moderate to severe heart valve disease, congenital heart disease, etc. other than evidence of congestive heart failure that is directly related to past ischemic events.
• •5. Left ventricular thrombus (mobile or mural-based) as evidenced by ventriculogram or echocardiography.
• •6. Creatine kinase (CK) levels \>3 x upper limit of normal (ULN).
• •7. Renal insufficiency requiring dialysis or laboratory evidence of a serum creatinine \>2.0 mg/dL.
• •8. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2 x ULN.
• •9. History of coagulation disorders or abnormal prothrombin time (PT) or partial thromboplastin time (PTT) \>1.5 x ULN, thrombocytopenia (\<100,000/µl), or ongoing anticoagulant therapy (with the exception of aspirin, up to 85 mg/day).
• •10. History of blood cell diseases.
• •11. Poorly controlled insulin-dependent diabetes mellitus (HbA1c \>8%)
• •12. Pre-existing retinal disease, including proliferative retinopathy, severe nonproliferative retinopathy.
• •13. Use of any illicit recreational drugs within the past year.
• •14. A positive test result for human immunodeficiency virus (HIV) antibody.
• •15. Screening ECG results demonstrating recent evidence of transmural ischemia.
• •16. Clinically significant ECG abnormalities, e.g.: QRS duration \>0.12 seconds; QTc \>450 ms in males or \>460 ms in females;High-grade trioventricular (AV) block; Left bundle branch block(LBBB; Left ventricular hypertrophy(LVH) with secondary ST-T changes; Frequent, recurrent, or sustained ventricular arrhythmia; Resting ST segment depression \>1 mm (measured 80 ms beyond the J point) at baseline.
• •17. Subjects having a concomitant life-threatening disease in which their life expectancy is estimated to be less than 2 years.
• •18. Any condition which in the opinion of the investigator would interfere with the participant's ability to provide informed consent and comply with study instructions, possibly confound interpretation of study results, or endanger the participant if he took part in the trial.
• •19. Use of an investigational drug, device or product, or participation in a drug research study within a period of 30 days prior to receiving IMP.
• •20. Any subject with unstable angina.
• •21. Heart failure New York Heart Association (NYHA) Functional Class III or IV.
• •22. Uncontrolled hypertension precluding exercise testing and/or contributing to angina severity (systolic blood pressure \[SBP\] \>200 mmHg or diastolic blood pressure \[DBP\] \>110 mmHg), or significant hypotension (SBP \<90 mmHg or DBP \<60 mmHg).
• •23. Subjects currently on External Counter Pulsation therapy or who have received this therapy within 3 months prior to the screening date.
• •24. Any mobility or pulmonary complication that impedes the subject's ability to perform an exercise stress test.
• •25. Total fasting serum cholesterol \>200 mg/dL (if levels greater than or equal to 200 mg/dL, additional medical interventions can be initiated to bring levels below 200 mg/dL).
• •26. History of heparin-induced thrombocytopenia.
• •27. Subjects with a history of recurrent symptomatic atrial fibrillation or significant ventricular arrhythmias.
• •28. Aortic or mitral valve replacement.
• •29. Subjects who have undergone heart transplantation.
• •30. Medical history and physical examination displaying any evidence that catheterization is contraindicated.